Open any shampoo, hair dye or sun cream and you will find a short line of small print telling you what not to do. These cosmetic label warnings are not decoration: for many products they are a legal requirement, and a missing or badly worded warning can stop a product from being sold. This guide explains which precautions are mandatory, where the wording comes from and how to check your own label before it goes to print.
Contents
- The short answer
- What the regulation says about warnings
- Where to find the required wording
- Typical examples (not a complete list)
- Warnings that come from your safety assessment
- Language: which languages must the warning be in?
- When the container is too small
- Common mistakes with label warnings
- Other rules that may add warnings
- A practical checklist before printing
- Warnings are not a substitute for safety
- Frequently asked questions
- Key takeaways
The short answer
In the EU, a cosmetic label must show the particular precautions for use, at the very least those listed in Annexes III to VI of Regulation (EC) No 1223/2009, plus any special precautions for professional-use products. The list is not a free-text field: if an ingredient you use carries a condition or warning in the annexes, that wording belongs on the pack. Your safety assessor can also require further warnings based on your formula, and they are recorded in the CPSR.
What the regulation says about warnings
Article 19 of the Cosmetics Regulation lists the information that must appear on the container and the packaging. Next to the responsible person, nominal content, durability, batch number, function and ingredients, it requires the particular precautions to be observed in use. The text refers to the precautions in Annexes III, IV, V and VI at a minimum, and to any special precautionary information for cosmetics intended for professional use.
In practice this means you do not invent warnings from scratch. You look up every ingredient and every restriction that applies to your product type, and you transfer the required wording faithfully.
Read also How to Label Small Cosmetic Containers and Samples
Where to find the required wording
The annexes are the backbone of the system. Each has a column for conditions of use and warnings where it applies:
- Annex III – substances that are allowed only with restrictions. This is where most mandatory warnings sit.
- Annex IV – permitted colourants, sometimes with conditions of use.
- Annex V – permitted preservatives, again with conditions where they apply.
- Annex VI – permitted UV filters, with conditions of use.
Not every substance has a warning. But when an entry has one, the wording is normally prescribed and should be used as written, translated faithfully into the local language.
Typical examples (not a complete list)
The following examples show the range of what you may meet. Always check the current text of the annex for your ingredient, because entries are amended from time to time.
- Oxidative hair dyes. Warnings about allergic reactions, an age limit for use, advice not to use on irritated or damaged scalps, and a note about temporary “black henna” tattoos.
- Hair products with hydrogen peroxide. Typically a warning to avoid contact with the eyes.
- Some salicylic acid products. An age restriction for very young children, depending on the product type.
- Nail hardeners and similar products with formaldehyde. A specific warning about protecting the cuticles and the presence of the substance.
These are illustrations only. Your own product may fall under entries not mentioned here, and some entries only apply above a given concentration or for certain product types such as leave-on or rinse-off.
Warnings that come from your safety assessment
Beyond the annexes, the safety assessor looks at your formula, the way consumers use it and the people who might use it. The CPSR Part B contains a section on labelled warnings and instructions of use. Typical outcomes are statements such as “for external use only”, “avoid contact with eyes”, “stop use if irritation occurs” or “keep out of the reach of children”. The law does not give one standard sentence for these; the assessor decides which are needed and your label must reflect them.
That is why the warnings on a label should always match the CPSR. If the assessor asks for a warning and the pack does not carry it, the file and the product disagree.
Read also EU Cosmetic Label Requirements: Complete Checklist
Language: which languages must the warning be in?
The language of the precautions is determined by the law of the Member State where the product is made available to the end user. Many countries require their official language, and some accept additional languages. If you sell across the EU, plan the label layout early, because a warning that needs five translations takes much more space than one in a single language. Remember that a translation of a warning must keep the meaning exactly; do not shorten it to fit.
When the container is too small
The regulation allows an alternative when, for practical reasons, the information cannot be printed on the container. The precautions can then be provided on an enclosed leaflet, label, tape, tag or card, and the container carries the open-hand symbol that refers the user to that information. For soap, bath balls and other small products, the ingredient information may be shown on a notice next to the product at the point of sale. Treat this as a last resort and not as a way to avoid a long label. Our guide to small containers and samples goes deeper into the practical side.
Common mistakes with label warnings
- Copying a competitor’s warning without checking whether your formula needs the same one.
- Paraphrasing prescribed wording so that it is shorter or friendlier.
- Printing warnings only on the outer carton, so that the bottle itself is unlabelled.
- Forgetting reformulations. A new ingredient or a changed concentration can add or remove a warning.
- Using an old text. Annex entries are updated; check the current version.
- Illegible print. Information must be indelible, easily legible and visible. A warning in tiny, low-contrast type can be treated as missing.
Read also Cosmetic Label Function: When You Must State the Product Function
Other rules that may add warnings
Some product formats have their own rules outside the Cosmetics Regulation. Aerosol dispensers, for example, are covered by the Aerosol Dispensers Directive, which sets requirements for their marking, including flammability. Cosmetics themselves are generally outside the CLP labelling system for finished products, but the raw materials you buy come with CLP hazard information in their safety data sheets, and that information helps your assessor decide what to write. Always confirm with your responsible person whether any additional national requirement applies.
A practical checklist before printing
- List every ingredient and its concentration.
- Check each against Annexes III to VI for conditions and warnings.
- Confirm the product type: leave-on, rinse-off, professional use, children, sprayed.
- Ask your safety assessor for the warnings in the CPSR Part B.
- Check the languages of every market you sell in.
- Check the size, contrast and position of the text on every pack, including the bottle and the box.
- Keep the final artwork in your product information file.
A CPSR is the document that ties these steps together. Evidence from a patch test or a stability test can support decisions about warnings and instructions for use, and all of it ends up in the product information file.
Warnings are not a substitute for safety
A warning cannot make an unsafe formula safe. The safety assessment must conclude that the product is safe under normal or reasonably foreseeable conditions of use with the labelled warnings in place. If the only way to make a product acceptable is a long list of warnings, that is a sign to look at the formula again.
Frequently asked questions
Do all cosmetics need a warning?
No. A product only needs warnings if an annex entry, the safety assessment or another rule calls for them. Many simple products need none beyond common-sense statements chosen by the assessor.
Can I use symbols instead of text?
Only the symbols provided for in the regulation, such as the open-hand symbol that refers to enclosed information. A symbol you design yourself does not replace a required warning.
Who is responsible for the warnings on the label?
The responsible person. Distributors must check that the required labelling is present before they sell the product.
Key takeaways
- Precautions for use are mandatory label information in the EU, at the very least those in Annexes III to VI.
- Use prescribed wording as written and translate it faithfully.
- Your CPSR may add further warnings; label and file must match.
- Re-check warnings every time the formula, the pack or the market changes.